BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM

    MDR report key: 12215627 · Received July 22, 2021

    Report

    Report Number
    2015691-2021-04304
    Event Type
    Death
    Date Received
    July 22, 2021
    Date of Event
    July 1, 2021
    Report Date
    August 6, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AS ADDITIONAL CLARIFICATION WAS RECEIVED, CLARIFYING THAT IT WAS A PERFORATION IN THE APEX, PROBABLY DUE TO THE GUIDE WIRE, THIS REPORT IS TO CORRECT THE DEVICE IT WAS REPORTED AGAINST.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691- 2021- 04303. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES, INCLUDING PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE SEVERAL POTENTIAL ETIOLOGIES FOR VENTRICULAR PERFORATION DURING A TAVR PROCEDURE, INCLUDING PERFORATION BY THE GUIDEWIRE, THE DELIVERY SYSTEM, OR THE TRANSVENOUS PACER (TVP) LEAD. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PROPER GUIDEWIRE POSITIONING, FIXATION OF THE TVP TO PREVENT VENTRICLE PERFORATION, AND CAREFUL MANIPULATION OF DEVICES. PER THE PROCEDURE DIDACTIC, PATIENTS WITH SMALL VENTRICLES ARE AT PARTICULARLY HIGH RISK FOR VENTRICULAR PERFORATION. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST THE PATIENT HAD FRAIL TISSUE AND A WIRE PERFORATION LED TO THE PATIENT'S DEATH. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED. DEVICE NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATES IN (B)(6), DURING THE TRANSFEMORAL PROCEDURE, THE 26MM SAPIEN 3 ULTRA VALVE EMBOLIZED INTO THE AORTA. A SECOND VALVE (29MM SAPIEN 3) WAS IMPLANTED AFTER REANIMATION WHICH SHOWED MASSIVE AI DESPITE GOOD IMPLANTATION. CARDIAC TAMPONADE WAS SEEN, AND THE PATIENT DIED. THE AUTOPSY CONFIRMED NO ANNULAR RUPTURE, VERY FRAIL TISSUES AND A PERFORATION IN THE APEX, PROBABLY DUE TO THE GUIDE WIRE. THE AI WAS DUE TO THE APEX PERFORATION, AVOIDING PROPER PRESSURE GENERATION FROM THE HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106843 EDWARDS COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9610TF29 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| R